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    The EU Clinical Trials Register currently displays   43801   clinical trials with a EudraCT protocol, of which   7263   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    EudraCT Number:2017-004923-63
    Sponsor's Protocol Code Number:C21
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-12-20
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2017-004923-63
    A.3Full title of the trial
    A phase 2, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of C21 in patients with Idiopathic Pulmonary Fibrosis (IPF)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test the safety, tolerability, and the effects of C21 in patients with Idiopathic Pulmonary Fibrosis (IPF)
    A.4.1Sponsor's protocol code numberC21
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorVicore Pharma AB
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportVicore Pharma AB
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVicore Pharma AB
    B.5.2Functional name of contact pointKicki Johansson
    B.5.3 Address:
    B.5.3.1Street AddressPepparedsleden 1
    B.5.3.2Town/ cityMölndal
    B.5.3.3Post code43183
    B.5.4Telephone number+46706251565
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameC21
    D.3.4Pharmaceutical form Oral solution in single-dose container
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPD00377 Na-salt
    D.3.9.3Other descriptive nameCOMPOUND 21
    D.3.9.4EV Substance CodeSUB182630
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral solution in single-dose container
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Idiopathic Pulmonary Fibrosis (IPF)
    E.1.1.1Medical condition in easily understood language
    IPF is a chronic and ultimately fatal disease characterized by a progressive decline in lung function. Pulmonary fibrosis means scarring of lung tissue, the cause of worsening shortness of breath.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10021240
    E.1.2Term Idiopathic pulmonary fibrosis
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety and tolerability of C21 in patients with IPF.
    E.2.2Secondary objectives of the trial
    Secondary objectives are evaluation of:
    • Biomarkers (C1M, C3M, PRO-C3).
    • Lung function.
    • Pharmacokinetics of C21 in IPF patients.

    Exploratory objectives are evaluation of:
    • Exploratory biomarkers related to IPF.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients will be entered into this study only if they meet all of the following criteria:
    1. Written informed consent consistent with ICH-GCP and local laws signed prior to entry into the study.
    2. Male patient or female patient of non-childbearing potential with IPF (for definition of woman of childbearing potential [WOCBP], refer to protocol section
    3. Patients >60 years of age.
    4. Patients with a FVC ≥45% predicted and an FEV1/FVC ratio ≥0.7 before bronchodilator.
    5. Patients with oxygen saturation (SpO2) >85% by pulse oximetry while breathing ambient air at rest.
    6. Patients with a diagnosis consistent with IPF prior to screening based on ATS/ERS/JRS/ALAT (American, European, Japanese and Latin American Respiratory Societies) consensus criteria.
    7. Patients with a diffusing capacity (DLCO - transfer factor of the lung for carbon monoxide) >20%.
    8. Patients with longitudinal factors in past 12 months associated with an increased risk of mortality related to IPF according to ATS/ERS/JRS/ALAT consensus criteria: either a documented increased level of dyspnea, a decrease in FVC by ≥10% absolute value, a decrease in DLCO by ≥15% absolute value, a worsening of fibrosis on high resolution computed tomography (HRCT) confirmed in the radiologist report.
    E.4Principal exclusion criteria
    Patients will be entered into this study only if they meet none of the following criteria:
    1. Concomitant use of angiotensin receptor blockers (ARBs).
    2. Concomitant or previous (2 months) use of nintedanib or pirfenidone.
    3. Current smoker.
    4. HRCT pattern showing emphysema more than the extent of fibrosis of the lung area, conducted within 12 months of Day 1.
    5. Use of systemic immunosuppressants within 30 days of Day 1.
    6. Patients currently receiving oral corticosteroids, cytotoxic drugs (e.g., chlorambucil, azathioprine, cyclophosphamide, methotrexate), vasodilator therapies for pulmonary hypertension (e.g., bosentan), unapproved (e.g., interferon-γ, penicillamine, cyclosporine, mycophenolate) and/or investigational therapies for IPF or administration of such therapies within 4 weeks of initial screening.
    7. Patients treated with strong inhibitors and inducers of CYP3A4 either during the study or 14 days prior to enrolment in the study: antifungals (e.g., ketoconazole, itraconazole), clarithromycin, telithromycin, cobicistat, protease inhibitors (e.g., atazanavir, ritonavir, and saquinavir) and grapefruit juice, phenytoin, carbamazepine, barbiturates, rifampin and St. John's Wort).
    8. Long QT syndrome (LQTS).
    ­- A marked baseline prolongation of QT/QTc interval (demonstration of a QTc interval >450 milliseconds)
    ­- A history of additional risk factors for Torsade de Pointes (TdP) (e.g., heart failure, hypokalemia, family history of LQTS)
    ­- Use of concomitant medications that prolong the QT/QTc interval.
    9. PR-interval >0.2 seconds or any AV block or QTc intervals >500 msec, calculated with Bazett’s method of correction [QTc=QT/RR E^1/2].
    10. Patients newly prescribed (<3 months at screening) glycosides, beta-blockers, calcium channel blockers, and cholinesterase inhibitors.
    11. Documented orthostatic hypotension as well as patients with a diastolic blood pressure less than 60 mmHg and a systolic blood pressure less than 110 mmHg.
    12. History of (or current) asthma requiring daily maintenance treatment.
    13. Participation in a clinical study of an unlicensed drug in the previous 4 months, or a marketed drug study within the previous 3 months.
    14. At baseline/screening visit, values of liver transaminases above 3 times upper limit, alkaline phosphatase above 2.5 times upper limit, or bilirubin above 1.5 times upper limit.
    15. Creatinine clearance (CrCl) <60 ml/min (determined by Cockcroft-Gault Equation) at baseline/screening visit.
    16. Abnormality of cornea (other than scars, congenital abnormality or corneal tearfilm insufficiency).
    17. Currently receiving drugs with known corneal toxicity (e.g., hydroxychloroquine, amiodarone, tamoxifen, and chlorpromazine).
    18. History of dry-eye syndrome (e.g., Sjogren’s syndrome).
    19. History of ocular surface abnormality (including Stevens–Johnson syndrome and alkali burns).
    20. Eyes within a previous radiotherapy field.
    21. Current use of contact lenses (previous contact lens wearers are eligible if their eye examination is within normal limits).
    22. Contraindication to cataract surgery.
    23. Clinically relevant cataract with impact on vision as diagnosed by an eye physician before or at screening.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of Adverse Events (AEs) reported by the subject or observed by the Investigator
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Screening Period (Day -28) to the end of Follow Up-Period (Day 57+2)
    E.5.2Secondary end point(s)
    Withdrawn consent of the patient
    E.5.2.1Timepoint(s) of evaluation of this end point
    From Screening Period (Day -28) to the end of Follow Up-Period (Day 57+2)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United Kingdom
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 30
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-02-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-04-22
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